Ferumoxytol Treatment Group (n = 486) | Iron Sucrose Treatment Group (n = 281) | Total (N = 767) | |
---|---|---|---|
AE Summary | |||
All AEs | 206 (42.4) | 141 (50.2) | 347 (45.2) |
Treatment-related AEs | 66 (13.6) | 45 (16.0) | 111 (14.5) |
SAEs | 24 (4.9) | 11 (3.9) | 35 (4.6) |
Treatment-related SAEs | 3 (0.6) | 1 (0.4) | 4 (0.5) |
AEs of Special Interesta | 12 (2.5) | 15 (5.3) | 27 (3.5) |
Cardiovascular AEsb | 6 (1.2) | 3 (1.1) | 9 (1.2) |
AEs resulting in temporary discontinuation of study drug | 3 (0.6) | 4 (1.4) | 7 (0.9) |
AEs resulting in permanent discontinuation of study drug | 7 (1.4) | 9 (3.2) | 16 (2.1) |
AEs resulting in study discontinuation | 4 (0.8) | 6 (2.1) | 10 (1.3) |
Death | 1 (0.2) | 0 (0.0) | 1 (0.1) |
Treatment-emergent AEs occurring in ≥2 % of patients in any treatment group by decreasing incidence in the Ferumoxytol Treatment Group | |||
Headache | 22 (4.5) | 13 (4.6) | 35 (4.6) |
Nausea | 17 (3.5) | 10 (3.6) | 27 (3.5) |
Dizziness | 10 (2.1) | 5 (1.5) | 15 (2.0) |
Dysgeusia | 10 (2.1) | 14 (5.0) | 24 (3.1) |
Peripheral edema | 5 (1.0) | 8 (2.8) | 13 (1.7) |
Urinary tract infection | 5 (1.0) | 9 (3.2) | 14 (1.8) |
Muscle spasms | 5 (1.0) | 6 (2.1) | 11 (1.4) |
Vomiting | 4 (0.8) | 6 (2.1) | 10 (1.3) |
Hypotension | 3 (0.6) | 10 (3.6) | 13 (1.7) |
Pyrexia | 2 (0.4) | 7 (2.5) | 9 (1.2) |